Is AI Tech Secure validated for FDA 21 CFR Part 11?
The Pharma GxP Assurance pack includes 21 CFR Part 11 e-signature attestation, IQ/OQ/PQ validation records, immutable audit chains, and change freeze capabilities for regulated environments.
Identity Governance Validated for Regulated Life Sciences
GxP-ready IGA with FDA, HIPAA, 340B, and 21 CFR Part 11 — from access control to audit evidence.
Pharma and biotech companies cannot afford identity governance gaps — FDA inspections, 21 CFR Part 11 violations, and HIPAA breaches carry existential risk. AI Tech Secure delivers a validated IGA + GRC platform with pharma-specific controls baked into P2P, O2C, PAM, and compliance modules.
Industry-Specific Capabilities
GxP Assurance PackIQ/OQ/PQ validation records, go-live checklist, OQ probes
21 CFR Part 11E-signature attestation, immutable audit chain, change freeze
P2P Pharma ControlsSupplier qualification (FDA), track & trace, cold chain, expiration
O2C Pharma Controls340B pricing, patient assistance programs, adverse event escalation
HIPAAPrivacy controls across P2P/O2C processes and database masking
Auditor PortalRead-only Big 4 auditor access — no configuration changes
Firefighter + ReplayPrivileged session evidence for GxP inspections
GxP Audit Pack ExportOne-click ZIP with campaigns, findings, evidence, approvals
Self-Hosted AIRole design and SoD remediation without cloud AI APIs
Pain Points → Solutions
Challenge: Validated SaaS access control
AI Tech Secure: GxP Assurance wizard with validation mode
Challenge: FDA asks for privileged access evidence
AI Tech Secure: Session replay with firefighter audit trail
Challenge: 340B pricing compliance
AI Tech Secure: Dedicated O2C evaluator
Challenge: Supplier qualification gaps
AI Tech Secure: P2P FDA supplier qualification control
Challenge: Cloud AI blocked by QA
AI Tech Secure: Self-hosted ATS AI on your infrastructure
Challenge: External auditor needs read-only access
AI Tech Secure: Auditor Portal with grant-scoped visibility
FAQ
Does AI Tech Secure support 340B pricing compliance?
Yes. The O2C Controls module includes a dedicated 340B pricing compliance evaluator with automated control runs and GxP audit pack evidence export.